Recalls / Class II

Class IID-0383-2024

Product

TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-158-15.

Affected lot / code info

Lot #: R608, Exp:04-21-2024, R609, Exp: 05-19-2024, R610, Exp: 07-28-2024, R611, Exp: 10-6-2024; R612, Exp: 02-02-2025, R613, Exp: 10-12-2025, R614, Exp: 11-02-2025

Why it was recalled

Lack of Assurance of Sterility

Recalling firm

Firm

Optikem International, Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

2172 S Jason St, N/A, Denver, Colorado 80223-4005

Distribution

Quantity

106,704 bottles

Distribution pattern

Product distributed Nationwide in the USA

Timeline

Recall initiated

2024-02-29

FDA classified

2024-03-12

Posted by FDA

2024-03-20

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0383-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.